Device and method for improved diagnosis and treatment of cancer

ABSTRACT

A device, in several configurations, which fixes a breast in distended, stable position using negative pressure, and minimizes or halts lymphatic flow from the breast. The invention allows for improvement in imaging and intervention in diagnosis and treatment of early stage human breast cancer. An image-guided system which allows accurate and bloodless access to breast tissue; guided by MRI or CT; using a unique saw and cautery device; in linear and rotary configurations to remove small or large lesions from the breast.

BACKGROUND OF THE INVENTION

[0001] For more than a century, it has been understood that breastcancers spread from the breast primarily by entering into and passingalong lymphatic channels draining the breast. These channels pass intothe armpit, into the skin and through the chest wall. Tumor spread ispartly impeded by the presence of lymph nodes; in which tumor cells canremain and grow, or pass though and into the blood stream. Near the turnof the century, William Halsted proved the utility of this knowledge bysurgically removing all possible lymphatic channels in addition toremoving the breast. While this had the disadvantage of being a fairlymutilating procedure, he was able to reduce the rate of local recurrenceof breast cancer to six percent from the previously reported recurrencerate of fifty to eighty-five percent when only the breast was removed.

[0002] Since the time of Halsted, surgical approaches have moved awayfrom radical techniques toward tissue-sparing approaches. With theability of earlier detection, minimal surgery; coupled with radiationand/or chemotherapy, has achieved similar results in preventing localrecurrence. The problem of detection of tumor spread remains. Often,women who appear to have early stage disease will die of metastaticcancer despite a lack of evidence of spread. Therefore, breast cancerhas been called a “systemic disease.” This is most likely because cancercells can spread undetected through lymphatic pathways; often early inthe disease.

[0003] The primary determinant of survival in breast cancer is thepresence or absence of tumor cells within the axillary (armpit) lymphnodes. Axillary nodes are removed to detect tumor spread and preventrecurrence. Tumor spread into other lymphatics that drain the breast isstill undetectable, and probably accounts for cases of metastasis whenthe axillary lymph nodes are free of cancer. Lymphatic flow isdetermined by pressure and osmolar gradients. Increases in interstitialfluid or in externally applied pressure will enhance lymphatic flow.Entry of tumor cells into lymphatics is an active process of the tumorcells. Once in the lymphatic channels, tumor cells are carried alongpassively by the flow of lymphatic fluid. Any increase in interstitialfluid or pressure will, therefore, increase the rate of tumor spread.

[0004] Breast cancer can recur many years after initial treatment.Presumably, this is because of the undetectable spread of small numbersof tumor cells. While it has been known for many years that cutting intotumors can enhance their spread, present techniques of needle and corebiopsies do just this. It has been claimed that these maneuvers don'tspread cancer; however, the truth of these claims might not be apparentfor many years.

[0005] Presently, the modalities of palpation, x-ray, ultrasound, andMRI are used to detect human breast cancers. Some of these techniquesare used also for image-guided biopsy of breast tissue. Mammography isthe mainstay of current early detection of breast cancer. This techniquerequires the forceful compression of the breast between plates toachieve acceptable images. Other known detection techniques, aspreviously mentioned, include ultrasound, magnetic resonance imaging(hereinafter “MRI”), and computerized tomography (hereinafter “CT”).Ultrasound images of the breast are obtained using a probe placeddirectly against the skin of the breast. MRI images are made by placingthe breast in a magnetic field, between coils or hanging into a wellthat is surrounded by a coil. The principles of MRI are known to thoseof ordinary skill in the art. A description may be found in U.S. Pat.No. 5,437,280 to Hussman entitled “Magnetic Resonance Breast Localizer”which is hereby incorporated by reference in its entirety. Stereotacticbiopsy techniques are done in a similar fashion; with a patient lyingprone, with the breast hanging through a hole in the table. All thesemethods have shortcomings related to the flaccid nature of the breastwhich leads to difficulty in manipulating and orienting the organ.Additionally, some of these methods are very uncomfortable for thepatient. The pain often associated with the forceful compression of thebreast between plates in mammography being a prime example.

[0006] Early detection of breast cancers has spurred increasing interestin early intervention. Open biopsy techniques have given way to moreimage-guided biopsy methods which currently require forceful compressionof the breast for stabilization, and require the forceful passage ofinstruments into the breast which often cause considerable bleeding;especially once the compression has been released. The tissue is in adistorted state and accurate removal of a specific volume of breasttissue is difficult. Present techniques for image-guided biopsy of thebreast are limited by the size of the lesion to be removed, and bycontinuing challenges of bleeding and spread of tumor cells. Removal oflesions greater than a centimeter is generally not possible by thesemethods.

[0007] One object of the present invention is to allow for improvedimaging and intervention in diagnosis and treatment of cancer,particularly early stage human breast cancer. Another object of thepresent invention is to allow for the accurate removal of tissue in aminimally bleeding or bloodless field.

SUMMARY OF THE INVENTION

[0008] One embodiment of the invention is a fixation apparatus for abreast comprising a cup-like body having a side wall with an open topend and an open bottom end and a fluid evacuation duct. The body definesa chamber adapted to receive a portion of the breast. A gasket isattached to the bottom end and is adapted to provide a substantiallyfluid tight seal between the body and an area of skin around the breast.A suction ring is attached to the top end and is adapted to provide asubstantially fluid tight seal between the body and a second area on thebreast. The apparatus may further include a hose attached to the fluidevacuation duct and connected to a pump capable of evacuating fluid inthe cup-like body and mounted on the breast such that the gasket andsuction ring provide a substantially fluid tight seal between the bodyand the first and second areas.

[0009] Another embodiment of the present invention is also a fixationapparatus for a protuberance of a body that comprises a cup-like bodyhaving a continuous wall and a port. The wall is open at one end and thewall defines a volume adapted to receive the protuberance without theprotuberance contacting the wall. A gasket is attached to and adapted toprovide a substantially fluid tight seal between the body and an area ofskin around the protuberance. The fixation apparatus may further includea tubular member connecting the port to a pump for removing fluid tocreate a reduced or negative pressure within the volume and a pressuregauge connected to the fixation apparatus to monitor the pressure in thecup-like body.

[0010] Another embodiment of the present invention is a minimallyinvasive tissue saw. The tissue saw comprises a shaft extending along afirst axis between a proximal end and a distal end and has a first crosssection at the distal end. The tissue saw has a cutting head extendingbetween a connecting end and a cutting end. The connecting end ispivotally connected to the distal end of the shaft so that at least aportion of the cutting head is able to swivel back and forthsubstantially along a second axis, the second axis in a directiontransverse to the first axis. The cutting head has a cutting surface atthe cutting end and extends across a width in the second axis and isable to swivel back and forth to cut a slit in tissue. The slit has asecond cross section with the cutting head having at least one insertionsurface substantially adjacent the cutting surface. The insertionsurface extends between the connecting end and the cutting end andtapers from the first cross section at the connecting end to the secondcross section at the cutting end. A portion of the insertion surface isa cauterizing element and extends around a strip of the insertionsurface for cauterizing the tissue surrounding the slit.

[0011] In yet another embodiment the present invention is a minimallyinvasive device for removing a specimen of tissue with a cylinderextending along and rotatable around a first axis defined between aproximal end and a distal end. The cylinder has an interior surface andan exterior surface with a plurality of cutting arms. Each arm has aninner surface and an outer surface with the surfaces extending between aforward edge and a trailing edge. A portion of the forward edge definesa cutting edge and the cutting edge extends past the distal end of thecylinder to cut tissue. The arms are pivotally connected to the cylinderat the distal end and pivot between an open position and a closedposition. The inner surface of each arm is adjacent to and substantiallyoverlaps the exterior surface of the cylinder in the open position. Aportion of the inner surface of each arm extends beyond the distal endof the cylinder and is adjacent tissue in the closed position.

[0012] Another embodiment of the invention is a minimally invasivetissue biopsy device comprising a cannula having a proximal end and adistal end and a first longitudinal axis defined between the ends. Thedevice also includes a means for cutting a slit in tissue with the slitbeing in a second axis substantially transverse to the firstlongitudinal axis. The device further includes a trailing means forcauterizing substantially all of the tissue surrounding the slit.

[0013] Another embodiment of the invention is a method comprising:providing a retaining sleeve and a tissue saw. The retaining sleeve hasa proximal and a distal end with the retaining sleeve having a firstcross-section at the distal end. The tissue saw has an oscillatingcutting head and a trailing coagulating element. The head has a cuttingedge and a tapering insertion surface for advancing the retaining sleeveand the tissue saw along a first axis toward a lesion while the cuttingedge oscillates back and forth and cuts an entry wound in tissue. Theentry wound is a substantially linear slit having a secondcross-section. The entry wound is distorted from the secondcross-section of the slit to the first cross-section of the retainingsleeve. The tissue surrounding the slit is cauterized with the trailingcoagulating element. The cauterization occurs as the tissue saw andretaining sleeve are advanced toward the lesion.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014]FIG. 1 illustrates the prior art form of breast fixation usingcompression plates.

[0015]FIG. 2 is a side view partially in cross-section of an embodimentof the breast fixation apparatus of the present invention.

[0016]FIG. 3 is a partial sectional view of an alternative embodiment ofthe breast fixation apparatus of the present invention.

[0017]FIG. 4 is a enlarged perspective view of a portion of theembodiment of FIG. 3.

[0018]FIG. 5 illustrates an embodiment of a tissue saw and retainingsleeve being introduced into an incision in the breast while held by afixation apparatus of the present invention.

[0019]FIG. 6A illustrates a cross-section of the opening in the tissuecut by an embodiment of the tissue saw of the present invention.

[0020]FIG. 6B shows the transition between the cross-section of theopening cut into the tissue by a tissue saw of the present invention andthe cross-section of the shaft or retaining sleeve which trails thecutting surface of the tissue saw.

[0021]FIG. 7A is a top cross-sectional view of an embodiment of thetissue saw of the present invention.

[0022]FIG. 7B is a side cross-sectional view of the embodiment of FIG.7A.

[0023]FIG. 8A is an end view of FIG. 7A along the lines 1-1.

[0024]FIG. 8B is an end view of the embodiment of FIG. 7A along thelines 2-2.

[0025]FIG. 9 is a top cross-sectional view of one example of a drivingmechanism for the tissue saws of the present invention.

[0026]FIG. 10 is a perspective view of one embodiment of the coringdevice of the present invention.

[0027]FIG. 11A is an end view of the coring device of FIG. 10 in theopen position.

[0028]FIG. 11B is an end view of the coring device of FIG. 10 in theclosed position.

[0029]FIG. 12 is an illustration of the tissue saw being withdrawnthrough the retaining sleeve prior to encountering the lesion.

[0030]FIG. 13 is an illustration of the coring device of the presentinvention being advanced through the retaining sleeve toward the lesion.

[0031]FIG. 14 illustrates the path the coring device of one embodimentof the present invention cuts into the tissue surrounding the lesion tobe excised and the shape of the specimen of tissue cut.

[0032]FIG. 15 illustrates the coagulated cavity and coagulatedcollapsing slit left behind after the withdrawal of the devices of thepresent invention.

[0033]FIG. 16 is a top view of another embodiment of the tissue saw ofthe present invention.

[0034]FIG. 17A is a side view of another embodiment of the coring deviceof the present invention.

[0035]FIG. 17B is an end view of the embodiment of the coring device ofFIG. 17A.

[0036]FIG. 18A is a side view of the coring device of FIG. 17A in theclosed position.

[0037]FIG. 18B is an end view of the embodiment of the coring device ofFIG. 17A in the closed position.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] For the purposes of promoting an understanding of the principlesof the invention, reference will now be made to the embodimentillustrated in the drawings and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the invention is thereby intended, such alterations andfurther modifications in the illustrated device, and such fartherapplications of the principles of the invention as illustrated thereinbeing contemplated as would normally occur to one skilled in the art towhich the invention relates.

[0039] All of the above-mentioned methods, such as mammography,ultrasound, MRI, etc., have shortcomings related to the flaccid natureof the breast which leads to difficulty in manipulating and orientingthe organ. Additionally, some of these methods are very uncomfortablefor the patient. One particular and well known discomfort is thatassociated with mammography as illustrated in FIG. 1. Breast 10 has anipple 14 surrounded by an areola 12 which in turn is surrounded byperiareolar skin 13. Breast 10 protrudes from chest wall 16 and is shownforcefully compressed between compression plates 5, 6 which is necessaryto achieve acceptable images. This is in contrast to the situation foundin various embodiments of the present invention.

[0040] With reference to FIG. 2, an embodiment of the fixation device ofthe present invention in its simplest form is shown. The devicecomprises a cup-like body 20 defining a volume 21 containing the breast10. It should be understood that the term cup-like body may include avariety of different shapes. These shapes include, but are not limitedto, a frustospherical, frustoconical, generally hemispherical, funnelshaped, pyramidal, or even rectangular configurations which the cup-likebody 20 may possess so long as it is capable of enclosing at least aportion of the breast 10. The breast 10 again has an areola 12 andnipple 14. The breast 10 is attached to the chest wall 16 as shown inFIG. 2. The cup-like body 20 is attached to the chest wall 16 by meansof a flexible flanged gasket 22. It should be understood that ifcup-like body 20 is appropriately shaped at its bottom end where gasket22 is shown, the gasket 22 may instead be omitted and an adhesiveapplied directly to cup-like body 20 to attach it to the skin of thechest wall 16 or the breast 10. When such is the case, medical gradesolvents may be applied at a later time to remove the apparatus.

[0041] The cup-like body 20, surrounding the breast 10, can be evacuatedto varying degrees of negative pressure. While the flexible flangedgasket 22 is shown applied to the skin of the chest wall 16 around thebreast 10, it is understood that the gasket 22 may also be attacheddirectly to the skin of the breast 10 if so desired. The gasket 22allows a fluid-tight seal to be formed in the cup-like body 20. Air orother fluids are removed from the volume 21 containing breast 10 bymeans of a vacuum pump 24 while a distending pressure is monitored by apressure gauge 25. As the cup-like body 20 is evacuated, the breast 10is drawn into the cup-like body 20 toward the top surface 27 and awayfrom the chest wall 16.

[0042] Since negative pressure is applied to all surfaces of the breast10 evenly (as illustrated in FIGS. 2 and 3 with outwardly directedarrows), the breast 10 will expand to its maximum volume and remain in afixed position away from the chest wall 16. In this position, the breast10 can be placed in an imaging or interventional device 26. It should beunderstood that imaging or interventional device 26 may include, but isnot limited to, devices such as an MRI coil, an ultrasound device, a CTscanner, or a radiation beam with any of these devices placed around orat a distance from the breast 10. Since fixation of the breast 10 is notdependent on gravity, the patient need not lay prone, but instead may beplaced in many different positions for optimal advantage in imaging orirradiation as well as patient comfort.

[0043] With references to FIGS. 3 and 4, another embodiment of thepresent invention is shown which facilitates image-guided interventionof the breast 10. In this embodiment, the cup-like body 30 again has agasket 32 which together enclose a volume 31. As in the previousembodiment, cup-like body 30 may take a variety of configurations andshapes. The volume 31 enclosed includes at least a portion of the breast10. As before, the cup-like body 30 may include one or more hoses 33connected to a vacuum pump 34. In both embodiments, the cup-like body20, 30 will have an evacuation duct or port of some kind to which theflexible tubular member or hose may be attached to allow for evacuationof air or other fluids from within the body 20, 30. It is againpreferable to attach cup-like body 30 to the chest wall 16 by means ofgasket 32 (with or without the use of an adhesive as desired).

[0044] In this preferred embodiment, however, the periareolar skin 13 ispreferably left exposed. Thus, surgical intervention by a variety ofinstrumentation devices, one embodiment of which will be discussedfurther below, is possible through the periareolar skin 13. This isaccomplished by providing a suction ring 38 which is applied to theperiareolar skin 13 around the areola 12 of the breast 10. When the ring38 is applied, it provides access to the periareolar skin 13 of thebreast 10 outside the cup-like body 30, while maintaining negativepressure and fixation of the breast 10. Again, the distending pressureis preferably monitored by a pressure gauge 35. While suction ring 38 isshown applied to periareolar skin 13, it should be understood that avariety of sizes and locations for suction ring 38 are contemplated aswithin the scope of the invention. For example, suction ring 38 might beoval in configuration and not centered directly on the areola 12 thusexposing skin of breast 10 adjacent to the periareolar skin 13 if suchis preferred for easier access during surgical intervention. Similarly,ring 38 might be larger in diameter and placed lower down on the breast10 exposing more skin for easier access as required. It should also beunderstood that such variations in size and configuration are equallyapplicable to gasket 32. Thus, gasket 32 may be placed to create asubstantially fluid tight seal between both the skin of the breast 10 aswell as the skin of the chest wall 16 as desired.

[0045] The suction ring 38 is mounted on a adjustable stage 40 that canbe adjusted for varying sizes of breast 10. The adjustable stage 40 actsas a platform for a variety of image-guided devices. It should beunderstood that a variety of other platforms are contemplated as withinthe scope of the invention that may contain alternative translationaland/or rotational mechanisms for image-guided interventional devices. Byway of small incisions, in or around the areola 12 and periareolar skin13, various instruments and biopsy devices can be placed into thebreast: guided by images from x-ray, ultrasound, MRI, or CT.

[0046] With reference to FIGS. 3 and 4, it is seen that one suchadjustable stage 40 includes the ability for a 360 degreecircumferential adjustment as indicated by the arrow 44 as well as anextensible holder which allows for adjustment in the azimuth directionas indicated by the arrow 42. In its simplest form, the adjustable stage40 has a first portion 41 and a second portion 43. The first portion 41may be extended or retracted for adjustment in the azimuth direction andterminates in a first end 45 in which a variety of image-guided devicesmay be attached. The second end 46 of first portion 41 is connected tothe second portion 43 of adjustable stage 40. The second portion 43 ofadjustable stage 40 is generally ring shaped and first portion 41 may berotated about the circumference of second portion 43 and locked intoposition as desired. Similarly, the amount of extension of first portion41 is also adjustable. It is contemplated as within the scope of theinvention that the suction chamber defined by cup like body 20, 30 canbe of various sizes to accommodate equipment, coils, stages and thelike. It should be understood that the chamber may detach from theimaging or interventional devices or both so that the breast couldmaintain a static position in space, as when being placed, first, in animaging device and then into a targeting biopsy device. It should befurther understood that the unique aspect of the present invention isthe ability to stabilize the breast or other bodily protuberance in aposition in space and that a wide variety of configurations of thechamber are contemplated as within the scope of the invention forachieving this end.

[0047] In one preferred embodiment the patient is lying prone andslightly tilted, bringing the breast into position with the suctionchamber defined by the cup-like body. Then the imaging device may bearranged to be inside or outside the chamber, depending upon itsparticular requirements (e.g. —“surface coils” for MRI). As disclosedabove, in one embodiment a secondary suction ring maintains exposure ofthe areola for entry using a variety of interventional devices, inparticular biopsy devices. The secondary suction ring, being placed onan adjustable stage, aids in permitting a wide variety of configurationsin arranging the chamber, imaging device, and interventional device asappropriate for particular surgical applications.

[0048] As shown in FIGS. 3 and 4, after the cup-like body 30 isevacuated, and the breast 10 fixed, imaging devices 36 may be used tolocate precisely lesion 47 and then an interventional device shown as aline 48 in FIGS. 3 and 4 is inserted into the breast to precisely locateand excise the cancerous cells or tumor forming the lesion 47. A widevariety of interventional devices are contemplated for use in place ofline 48 in FIGS. 3 and 4. Such devices may include, but are not limitedto, those biopsy devices disclosed in U.S. Pat. Nos. 5,111,828,5,197,484, and 5,353,804 all to Kornberg et al. as well as U.S. Pat. No.5,795,308 to Russin and U.S. Pat. No. 5,817,034 to Milliman et al. allof which are hereby incorporated by reference. The preferredinterventional devices, however, will be disclosed below as yet anotherembodiment of the present invention.

[0049] Thus, by way of small incisions, in or around the areola 12,various instruments and biopsy devices (guided by images from suchthings as x-ray, ultrasound, MRI, or CT) may be used to precisely treatthe lesion 47 (or lesions) in the breast 10 which has been fixed inspace. As is known by those of ordinary skill in the art, anatomicallythe breast is arranged radially in duct-lobule units spreading out fromthe nipple-areolar complex. (See pages 20-21 of The Breast CancerSurvival Manual by John Link, M.D., published by Henry Holt and Company,Inc., 1998, these pages are herein incorporated by reference). Thefixation device of the present invention allows directed interventionalong radial anatomic compartments, and consequently, allows moreprecise anatomic alignment for diagnostic and therapeutic intervention.It is seen that the various embodiments described above of the presentinvention may be used to fix the breast in a distended, stable positionusing negative pressure. The stable fixation of the breast in space isadvantageous for breast imaging, tissue biopsy and specific localtherapy.

[0050] Additional utility of the present invention derives from itsability to temporarily minimize or halt lymphatic flow from the breastand, thereby, halt the spread of tumor cells via the lymphatics. This isin contrast to present techniques which generally involve the forceful(and potentially painful) compression of the breast between two plates.This externally applied pressure enhances lymphatic flow (thus havingthe potential to increase the rate at which tumor cells spread) asopposed to minimizing or halting it. It is understood by those ofordinary skill in the art that cancerous cells are less dangerous ifthey remain intraductal. If a cancer becomes invasive or interductal,there is greater opportunity for the cancerous cells to spread. Everytime a breast is compressed to the extent necessary to performmammography, pressure in the system is increased. Increasing thepressure in the system increases the likelihood that the cancerous cellswill either (1) be forced through the walls of the ductal tissue; and/or(2) increase the rate of lymphatic flow so that the cancer cells willfilter through the labyrinth of the lymph nodes and the lymphatic systemallowing the disease to spread to other portions of the body andprogress to the systemic stage from localized. Thus, in addition toderiving utility from minimizing or halting lymphatic flow, the fixationdevice of the present invention is advantageous simply because it doesnot increase the pressure on the system, as is the case with manyconventional techniques. The invention has further utility inapplications such as those involving external beam radiation treatment.Both of the above disclosed embodiments for a breast fixator draw thebreast 10 away from the chest wall 16 into a position more favorable tosafe and specific treatment. It should be understood that the dimensionsand materials of the above described embodiments can and will varywidely depending on the particular needs of the imaging or treatmentmodality. It should be further understood that the dimensions andmaterials of the device may also vary based on the size of the organ ofthe patient being treated.

[0051] Other advantages of the fixation device of the present inventionare numerous. For example, a breast fixator provides the ability tostabilize the breast in space, both for imaging and for intervention. Afixation device as disclosed in the present application has particularlyadvantageous features for use with MR. With the breast fixed in space,different modalities can be applied and the patient can be moved fromplace to place. For example, MRI imaging takes some time, and keeping apatient in the scanner while doing a procedure wastes time for otherimaging. However, by using a fixator to stabilize the breast as in thepresent invention, the breast can be imaged and the data/set ofinformation about the breast can be stored and regenerated andmanipulated. Once the data set is fixed, and the points on the fixatorare referenced, the breast can be manipulated in a different place withdifferent and cheaper localizing devices. In one preferred embodiment,the breast is fixed within a fixator which itself has coordinatemarkings. The breast is then imaged alone with the coordinating marks.The patient is then removed to an interventional area where, usingultrasound guidance within the superimposed data sets of ultrasound andMRI, the areas to undergo surgical intervention can be targeted. It iseven possible to integrate MRI, ultrasound, and CT images of the breastand use all that information simultaneously. It should be understoodthat variations of the above described method of use of the breastfixation of the present application that would be known to those ofordinary skill in the art, are contemplated as within the scope of theinvention. In particular, a variety of different imaging devices inconnection with the interventional devices discussed above as well asthe preferred embodiment discussed below are contemplated as within thescope of the invention.

[0052] With reference to FIGS. 5-18, there are illustrated variousembodiments of a tissue saw and coring device for use in a minimallyinvasive procedure in a minimally bleeding or bloodless field and forremoving a specimen of tissue. The specimen of tissue to be removed isthat surrounding and including a lesion 80 found using the earlydetection methods of present technology. As previously indicated, thevarious embodiments of the tissue saw and coring devices disclosed beloware intended to be used in conjunction with the breast fixation deviceof the present invention. It should be understood, however, that thedevices and methods disclosed below may be used independently of thefixation device described above. It should be further understood thatthe tissue saw and coring devices discussed below will find utility witha wide variety of imaging devices including MRI. One preferredembodiment for use with MRI imaging modalities is if the tissue sawanchor the coring device, as well as any retaining sleeve used, are madeof MR transparent materials. These MR transparent materials may includetitanium, plastic (polycarbonate), and other materials known to those ofordinary skill in the art.

[0053] With respect to FIGS. 5-9, there is illustrated one embodiment ofa minimally invasive tissue saw 101 for permitting access to a lesion 80in a minimally bleeding or bloodless field. The tissue saw 101 ispreferably first inserted through retaining sleeve 103. The retainingsleeve 103 may be held, for example, by the previously disclosed movablestage 40 (not shown) in the first portion 41 at the first end 45. Themovable stage 40 (not shown) is aligned so that the tissue saw 101 linesup with an incision 90 in periareolar skin 13 and/or adjacent areola 12and nipple 14. In its simplest form, the tissue saw 101 comprises ashaft 105 with an attached cutting head 110. The shaft 105 may be eithera generally hollow cylinder or a solid rod (with passages as necessaryfor cables or other means for swiveling the cutting head 110) extendingthrough the retaining sleeve 103. The retaining sleeve 103 isessentially a cylinder or cannula. A wide variety of shapes and formsother than the generally circular form shown for both the shaft 105 andretaining sleeve 103 are contemplated as within the scope of theinvention.

[0054] Shaft 105 has a proximal end 106 and a distal end 107. Shaft 105has a first cross-section 109 at distal end 107. The cutting head 110has a connecting end 112 and a cutting end 114. The connecting end 112of cutting head 110 is attached to the distal end 107 of shaft 105. Asillustrated in FIGS. 5 and 6, the shaft 105 has a first cross-section109 that is generally circular with a diameter 109 a. The shaft 105extends between the proximal end 106 and distal end 107 along a firstlongitudinal axis 108. The tissue saw 101 is intended to cut a slit 122.Slit 122 is cut by the cutting surface 120 of cutting head 110. Cuttingsurface 120 is shown with serrations 121. It should be understood thatthe use of serrations 121 at the cutting end of cutting surface 120,while preferred, is not necessary for operation of the presentinvention. Slit 122 is a long narrow aperture of minimal thicknesshaving a width 125. Width 125 is defined in a plane of the second axis116 which cutting head 110 creates by swiveling back and forth ofcutting surface 120 in the direction of the arrows 124 (see FIGS. 5 and7A).

[0055] While cutting surface 120 is illustrated as having serrations121, it should be understood that alternative embodiments wherein thecutting surface is a generally smooth blade are contemplated as withinthe scope of the invention. In one embodiment, cutting surface 120 is anarc of a circle and has a width 125 (in the second axis 116 transverseto the first axis 108) equal to the diameter of either shaft 105 orretaining sleeve 103. It should be understood, however, that a varietyof configurations and widths for cutting surface 120 are contemplated aswithin the scope of the invention. For example, cutting surface 120 maybe an arc of a circle, a straight blade, polygonal, or some combinationof the foregoing as known to those of ordinary skill in the art. Itshould be further understood that the cutting surface 120 may be aportion of the continuous perimeter of a generally circular bandsaw.This bandsaw may possess a wide variety of shapes and sizes. Forexample, the bandsaw may have a diameter at least equal to π/2 times thediameter of the shaft 105 or retaining sleeve 103 in which case nopivoting of the bandsaw would be necessary to cut a slit sufficientlylarge to encompass the retaining sleeve 103 or shaft 105. In anembodiment where the bandsaw had a diameter at least equal to π/2 timesthe diameter of shaft 105, the shaft 105 could be a generally hollowcylinder and the bandsaw could be detachable from the distal end 107 ofthe shaft 105, the bandsaw being collapsible so that it could beretracted through the shaft 105 and/or the retaining sleeve 103 asnecessary. It is also contemplated as within the scope of the inventionthat a bandsaw might be used with a diameter equal to the diameter ofthe shaft 105 or retaining sleeve 103. In this embodiment, the bandsawwould need to pivot from side to side as discussed further below. Thebandsaw could be rotated by various driving mechanisms known to those ofordinary skill in the art. One driving mechanism for a circular bandsawwould be an electric motor rotating in a continuous loop driving thecircular bandsaw.

[0056] Cutting head 110 has an insertion surface 130 which provides atransition from the first cross-section 109 of shaft 105 to the secondcross-section 123 of the slit 122. In the embodiments illustrated in thefigures of the present application, insertion surface 130 is generallyshown as comprising a first upper surface 132 having a first cauterizingplate or element 133 and a second lower surface 134 having a secondcauterizing plate or element 135. It should be understood, however, thatinsertion surface 130 may be an integral whole extending around theentirety of the cutting head 110 and transitioning between firstcross-section 109 and second cross-section 123. It should also beunderstood that instead of two surfaces 132 and 134, the insertionsurface 130 may instead be made up of a plurality of surfaces as opposedto merely two. The transition between the first cross-sectional shape109 of the shaft 105 and the second cross-sectional shape 123 of thesubstantially linear slit 122 may take a variety of configurations.

[0057] While upper surface 132 and lower surface 134 are shown as astraight line taper from the cutting surface 120 to the distal end 107of shaft 105, it should be understood that a variety of profiles for thetransition from the first cross section 109 of shaft 105 to the secondcross section 123 of slit 122 are contemplated as within the scope ofthe invention. For example, upper surface 132 and lower surface 134 maybe a series of steps, or a graduated transition that is concave orconvex in shape or some combination of these and other configurationsknown to those of ordinary skill in the art. In either case, the uppersurface 132 and lower surface 134 act to spread the tissue sliced bycutting surface 120 from the substantially linear slit 122 having secondcross-sectional shape 123 into a shape corresponding to the firstcross-sectional shape of shaft 105 or retaining sleeve 103.

[0058] The cutting head 110 is preferably pivotally connected to thedistal end 107 of shaft 105. In one embodiment, the entire cutting head110 will pivot. In other embodiments, however, only a portion of thecutting head 110 will be pivotally connected, such as the cuttingsurface 120. It should be understood that the term pivotally connectedencompasses those situations in which cutting surface 120 slides along atrack or other guide path located in between first upper surface 132 andsecond lower surface 134. In such an embodiment, the cutting surface 120will pivot from side to side generally along the second axis 116. Itshould be understood by those of ordinary skill in the art that thewidth 125 of slit 122 is preferably, but not necessarily, at least aminimum distance to gain maximum benefit of the improvements of thepresent invention. Namely, basic geometric principles (see FIG. 6B)reveal that the circumference of the shaft 105 should be approximatelyequal to twice the width 125 of the slit 122. Thus, to introduce theretaining sleeve 103 up to the point of the lesion in a minimallybleeding or bloodless environment, a cutting surface 120 of cutting head110 with a width 125 equal to the diameter of retaining sleeve 103should have the ability to pivot to each side a distance of (π/4- 0.5)times the diameter of the retaining sleeve 103 to be introduced into thebody.

[0059] As previously mentioned, either the cutting head 110 in itsentirety may swivel back and forth, or merely the cutting surface 120.In either situation, a variety of mechanisms are contemplated as withinthe scope of the invention for inducing the cutting surface 120 orcutting head 110 to swivel back and forth the necessary amount. Forexample, with reference to FIG. 7A and 8B, there is illustrated onedriving mechanism for the swivel action of cutting head 110. In thisembodiment, cables 140 a and 140 b running through cable shafts 142 aand 142 b are used to cause the necessary swiveling action. With respectto FIG. 9, there is shown a potential driving mechanism for the cables140 a and 140 b running through cable shafts 142 a and 142 b. In thiscase, the driving mechanism utilizes a spring block 144 and a cuttingtrigger 146 intended to be moved back and forth along an axis asindicated by the arrows 147 a and 147 b.

[0060] It should be understood that an essential element of the tissuesaw is the use of a cauterizing plate or element. The cauterizing plateor element may be placed on the cutting head 110, preferably, but notnecessarily, adjacent the cutting surface 120. Thus, as the tissue saw101 is advanced along the first axis 108, the tissue is first severed bythe cutting surface 120 and then quickly cauterized by, for example,first cauterizing plate or element 133 and second cauterizing plate orelement 135 so as to provide a minimally bleeding or bloodless field.This aids in preventing the spread of any tumor cells that mightotherwise be released to flow elsewhere in the body by the cutting ofthe tissue, in particular the tissue surrounding or near a lesion 80.The cauterizing elements 133 and 135 both destroy any tumor cellsencountered as well as causing coagulation in the tissue surrounding theslit 122.

[0061] The cauterizing elements 133, 135 may act to cauterize in avariety of manners including being an electrically resistive material sothat they may act as an electric cauterizer, or as a conduit for fiberoptic cables for laser coagulation and other mechanisms known to thoseof ordinary skill in the art. It should be understood that alternativelocations for the cauterizing plate or elements are contemplated aswithin the scope of the invention. For example, while the cauterizingplate or elements 133, 135 may be located either adjacent cuttingsurface 120 or elsewhere on the cutting head 110, it should beunderstood that the strip of material acting as a cauterizing elementmay be placed in a variety of locations. For example, the cauterizingelement could be a continuous strip of material placed around thecircumference of the distal end 107 of shaft 105 or might even be placedaround the circumference of a distal end of the retaining sleeve 103. Itshould be further understood in some situations the shaft 105 will be ahollow cylinder and may also be acting as the retaining sleeve 103. Inany case, the essential element of the tissue saw is that the cuttingsurface be followed by a trailing coagulating plate or strip of materialwhich acts to cauterize the tissue surrounding the opening cut into thebody by the cutting surface 120. It should also be understood that thefirst cauterizing element 133 and second cauterizing element 135 in theembodiment illustrated in the figures as well as discussed in thepreceding text, may be either affixed to the insertion surface 130 orfirst surface 132 and second surface 134 (or the exterior of the shaft105 or retaining sleeve 103 as may be the case) in a variety of mannersknown to those of ordinary skill in the art such as adhesives, welding,or being bolted on. Alternatively, it should also be understood that thecauterizing elements may be integrally formed upon whatever surface orsurfaces are selected for their location.

[0062] With respect to FIGS. 10 and 11, one embodiment of the coringdevice for removing the specimen of tissue containing the suspectedlesion 80 is illustrated. The device includes a cylinder 160 having aproximal end 161 and a distal end 162. The cylinder 160 extendsgenerally along a first axis 159, the cylinder 160 rotating around thefirst axis 159, both to cut a circumference of a circle in tissue aswell as rotating when cutting the bullet-shaped specimen 81 (see FIG.14B) free as discussed below. Cylinder 160 has an interior surface 163and an exterior surface 164. Cylinder 160 is preferably received withinretaining sleeve 103 so that the exterior surface 164 of cylinder 160 isadjacent the interior surface 104 a of the retaining sleeve 103.

[0063] It is understood that while it is preferred that the coringdevice be inserted up through the interior of the retaining sleeve 103,it is also possible to use a coring device with a cylinder 160 having adiameter 160 a such that the cylinder 160 may be rotated around theexterior surface 104 b of retaining sleeve 103. This is a less preferredembodiment, however, since the slit, (e.g., slit 122 with secondcross-section 123) while having been distended by the insertion surfaces(such as first upper surface 132 and second lower surface 134) to theshape of the shaft 105 and/or the retaining sleeve 103, would requireadditional cutting and cauterizing to pass the cylinder 160 around theexterior 104 b of retaining sleeve 103. In contrast, passing cylinder160 through the interior of retaining sleeve 103 permits theintroduction of the coring head 166 to the specimen of tissue 81surrounding the suspected lesion 80 to be removed without furthertrauma.

[0064] With respect to FIGS. 10 and 11, there are illustrated variousdetails of coring head 166. In the illustrated embodiment, coring head166 is shown with first cutting arm 170 and second cutting arm 180.First cutting arm 170 has an inner surface 171 a and an outer surface171 b extending between first forward edge 172 and first trailing edge173. At least a portion of first forward edge 172 comprises a cuttingedge 174 which may or may not be serrated as desired. Additionally, atleast a portion of the first outer surface 171 b of first cutting arm170 acts as a first cauterizing element 175. The first cauterizingelement 175 may be a coagulating plate or other means known to those ofordinary skill in the art for rapidly cauterizing the tissue cut byfirst cutting surface 174. First cutting arm 170 is generally swiveledaround a first hinge 178 near first pivoting end 176. Distal from firstpivoting end 176 is first far end 177. A first cable (or rod) 190 may bepulled so that first cutting arm 170 swivels from its open position (seeFIG. 11A) to its closed position for a completed cut (see FIG. 11B).

[0065] In a similar manner, second cutting arm 180 has a second innersurface 181 a and a second outer surface 181 b extending between asecond forward edge 182 and a second trailing edge 183. Second forwardedge 182 has a second cutting edge 184 along at least a portion ofsecond forward edge 182. It should be understood that second cuttingedge 184, similar to first cutting edge 174, may or may not be serratedas desired. Also, second cutting arm 180 has a second cauterizingelement 185 which, similar to first cauterizing element 175, may beattached or integrally formed with second outer surface 181 b. As seenin FIGS. 10 and 11, second cutting arm 180 swivels from an open positionto a closed position around a hinge 188 attached nearer to pivoting end186 than to far end 187. Second cutting arm 180 is pivoted from its openposition to its closed position using a second cable (or rod) 191 whichis preferably attached near the pivoting end side of the second cuttingarm and pulled, or which may instead be attached near the second far end187 of second cutting arm 180 and pushed to force the second cutting arm180 to swivel from its open position to its closed position. In the openposition, second inner surface 181 a is substantially adjacent theexterior surface 104 b of retaining sleeve 103. In the closed position,the cutting edge 184 and cauterizing element 185 will have cut a bulletshaped specimen 81 (see FIGS. 14A-B) and cauterized the tissuesurrounding the specimen 81 to be removed. It should be understood thatfirst and second cauterizing elements 175, 185 are preferably, but notnecessarily, found only on first and second outer surfaces 171 b, 181 b,respectively. Thus, the tissue specimen 81 being removed is preservedfor microscopic analysis and further examination.

[0066] The cables 190, 191 will cause first and second arms 170, 180 toswivel across an approximately 90 degree arc from the open position tothe closed position. A variety of mechanisms are contemplated as withinthe scope of the invention for causing the far ends 177, 187 of thefirst and second arms 170, 180 to curve inwardly toward one another andtoward the first axis 159 about which the cylinder 160 rotates. Onemechanism would be to manufacture the first and second arms 170, 180 outof a material having a memory. The memorized shape would be the inwardlycurved shape of the closed position. As the first and second arms 170,180 extended past the distal end of the cylinder 160, they would take ontheir memorized shape and the far ends 177, 187 would bend inwardlytoward one another while rotating to cut free the dome shape at the endof the bullet-shaped specimen of tissue 81 to be removed. The arms maybe made of a variety of materials such as stainless steel having asufficient elastic strength, or even a shape memory material, such asnickel titanium alloy. Alternatively, a pair of springs (not shown)could be placed between the inner surfaces 171 a, 181 a of first andsecond cutting arms 170, 180 and the exterior surface 164 of cylinder160. These springs would drive the pivoting ends 176, 186 away from theexterior surface 164 of cylinder 160 and would simultaneously cause thefar ends 177, 187 to move inwardly toward the first axis 159 aroundwhich cylinder 160 rotates. It should be understood that a supportingarmature which prevents the first and second cutting arms 170, 180 fromreturning to their memorized shape may be an apparatus attached to thecylinder 160 or the cylinder 160 itself may act as the supportingskeleton or framework.

[0067] The following is a description of the method of use of oneembodiment of the above-described devices for use in permitting accessto tissue surrounding a lesion in a minimally bleeding or bloodlessfield. The following also describes a method of use of one embodiment ofdevices in excising a specimen of tissue surrounding a lesion.Variations using other embodiments of devices disclosed above and belowand other devices known to those of ordinary skill in the art arecontemplated as within the scope of the invention.

[0068] For example, in one method of use, the second suction ring 38 ismounted on the movable stage 40 which has a targeting assembly (41, 42),which will adjust to 360 degrees and variable azimuth. Once the breast10 is fixed in space, and the coordinates for the lesion 80 aredetermined, an incision 90 is made in or around the areola 12.Generally, incision 90 will be made by the surgeon using an ordinaryscalpel or other cutting means known to those of skill in the art topreserve the skin's contour. Practicing surgeons will understand thatthe incision 90 and the scar it leaves behind are often the only visiblemeasure a patient will have to use to judge the quality of the surgeon'swork. Thus, it is preferable if incision 90 is made in a manner topreserve the skin's contour. It should be understood, however, that ifdesired, the tissue saw 101 may be used to create the incision 90 aswell. After the incision 90 is made, the tissue saw 101 is advanced intothe breast 10 toward the lesion 80. Around the tissue saw 101 is alsoadvanced the retaining sleeve 103. It should be understood in someembodiments of the device the shaft 105 will be a hollow cylinderthrough which the cutting head 110 and other diagnostic andinterventional devices may be extended through and retracted asnecessary. In such cases, there may not be any need for a separateretaining sleeve 103.

[0069] It should also be understood that a wide variety of shapes andcontours for the interior and exterior surfaces of the retaining sleeve103 are contemplated as within the scope of the invention. For example,the retaining sleeve 103 may have an exterior surface 104 b with aplurality of notches in it to act as a locking mechanism for more securefixation to the targeting assembly (41, 42) and in particular whateverholding mechanism the first end 45 of the first portion 41 of movablestage 40 may have. Alternatively, it should be understood that theexterior surface 104 b of retaining sleeve 103 may also be smooth andfirst end 45 may be a clamp permitting infinite variation in adjustingthe position of retaining sleeve 103 with respect to the first end 45. Atissue saw 101 has an oscillating cutting head 110 with a leadingcutting surface 120, which is preferably, but not necessarily providedwith a plurality of serrations 121. The cutting head 110 has a trailingdouble coagulating plate (133, 135)—the tissue being first cut, and thenexposed to cautery on both faces of the slit 122. Again, it isunderstood that the cauterizing element may be adjacent the cuttingsurface 120 or located some distance from it. Additionally, it should befurther understood, that as previously discussed, the coagulating plateor other cauterizing element while preferably located on cutting head110, may instead be located on shaft 105 or retaining sleeve 103.

[0070] As the tissue saw 101 is advanced, the substantially linear slit122 will be enlarged to the cross-section 109 of shaft 105. The tissuesaw 101 has a cutting edge 120 which is pivoted back and forth using adriving mechanism such as cables 140 run in the shaft 105. It should beunderstood that the cutting head 110's coagulation mechanism of firstcauterizing plate 133 and second cauterizing plate 135 could be replacedwith other mechanisms known to those of ordinary skill in the art suchas a laser coagulating strip, or a series of fiber optic parts fortrailing coagulation. The tissue saw 101 enables the placement of theretaining sleeve 103. The tissue saw 101 is then withdrawn (see FIG. 12)before the lesion 80 is encountered and the coring head 166 ispreferably advanced (see FIG. 13) through the sleeve 103. It should beunderstood that retaining sleeve 103 permits introduction of otherexcisional devices and/or other diagnostic tools in a minimally bleedingor bloodless field.

[0071] In particular, it should also be understood that the coring head166 could instead be advanced around the exterior surface 104 b ofretaining sleeve 103 as opposed to through the interior of the retainingsleeve 103. This is a less preferred embodiment, however, since thecoring head 166 would then have to be rotated in its open position (seeFIG. 11A) around the exterior surface 104 b of the retaining sleeve 103until it reached the distal end of the retaining sleeve 103. This wouldbe less preferred to some extent since the coring head 166 would beinducing further trauma to the tissue as it was rotated and slicedthrough the tissue that was formerly adjacent the slit 122. However,such would not be unacceptable since coring head 166 also includescauterizing elements or coagulating plates 175 and 185 on first cuttingarm 170 and second cutting arm 180, respectively. Thus, the goal of aminimally bleeding or bloodless field would still be achieved.Additionally, the exterior surface 104 b of the retaining sleeve 103would in this embodiment act as an armature or supporting frameworkwhich would prevent the first cutting arm 170 and second cutting arm 180from moving to their closed position until the extended past the distalend of retaining sleeve 103. This varies somewhat from the preferredembodiment in which a supporting skeleton or framework may be necessaryat the distal end of the cylinder 160 around which the first cutting arm170 and second cutting arm 180 are pivoted from their open position (seeFIG. 11A) to their closed position (see FIG. 11B). It should also beunderstood that in some embodiments the cylinder itself will act as thearmature supporting first cutting arm 170 and second cutting arm 180.

[0072] The remainder of the description of the method of use will bedirected to the more preferred embodiment in which the coring head 166is inserted through the retaining sleeve 103 as opposed to around theexterior surface 104 b of retaining sleeve 103. It should be understood,however, that the less preferred embodiments and their variations arecontemplated as within the scope of the invention and that thevariations in the method of use between the below disclosure of themethod of use for the most preferred embodiment and that for the lesspreferred embodiments will be readily apparent to those of ordinaryskill in the art. At the end of the retaining sleeve 103, the coringhead 166 will encounter the tissue and will begin to rotate. The twocutting arms 170, 180 will cut a cylinder of tissue using the cuttingsurfaces 174, 184, which preferably, but not necessarily includeserrations, and as the first and second cutting arms 170, 180 areadvanced and further rotated, the tissue will encounter the singleexternal coagulating trailing plates 175, 185.

[0073] The 90 degree arc cutting arms 170, 180 are opposite each otheracross the diameter 160 a of the coring head 166. As the coring head 166is advanced beyond the lesion 80, the cutting arms 170, 180 are rotatedbeyond the end of the cylinder 160 as the cylinder 160 is no longeradvanced. The arms will cut a “dome” (see FIG. 14A) beyond the end ofthe lesion plug 80 producing a bullet-shaped specimen 81 (see FIG. 14B).The entire device, along with the specimen 81, is withdrawn leaving abullet-shaped coagulated cavity 82 and a coagulated collapsing slit 122(see FIG. 15). It should be understood that the cutting arms 170, 180may be rotated beyond the end of the cylinder by a variety ofmechanisms. These mechanisms include such things as cables 190 and 191attached near the pivoting ends of the respective cutting arms, or rodsattached near the far ends of the respective arms to force them awayfrom the distal end of the cylinder 160. Additionally, further forcesdirecting the cutting arms from the open to the closed position may begenerated by the use of springs placed in between the interior surfaceof the pivoting end of the cutting arms and the exterior surface of thecylinder 160.

[0074] With reference to FIG. 16, an alternative embodiment cutting head210 is shown with like elements labeled as previously. Cutting head 210has upper surface 232 and lower surface 234. In this embodiment, afterthe tissue encounters cauterizing elements 233. 235, it would thenencounter a series of orifices 238 on the upper surface 232 and lowersurface 234 of cutting head 210. These orifices 238 provide an injectionport for the injection of anti-cancer agents, blood coagulationmaterials, and perhaps even polymeric substances to allow for the slowand somewhat controlled release of anti-cancer agents. The anti-canceragents may include standard chemotherapeutic agents such asanti-metabolites which interrupt cell division. The anti-cancer agentsmay also be more specific surface receptors known to those of ordinaryskill in the art such as tamoxifen or monoclonal antibodies. Adescription of one combination of blood coagulation agent, anti-canceragent, and polymers is found in U.S. Pat. No. 4,536,387 to Sakamoto etal. which is hereby incorporated by reference. Due to the extremetoxicity of some anti-cancer agents, the application of the anti-canceragents is thus made directly to the tissue surrounding the area of thelesion to be excised.

[0075] With reference to FIGS. 17 and 18 there is illustrated anotherembodiment of the coring device of the present invention. A coringdevice includes a barrel or cylinder 260 extending along a first axis259 about which it rotates. The barrel 260 extends along first axis 259between proximal end 261 (not shown) and distal end 262. The barrel 260has an interior surface 263 and an exterior surface 264. At the distalend 262 of barrel 260 is the coring head 266. Coring head 266 includesfirst, second and third cutting arms 270, 280, 290 each having innersurfaces 271 a, 281 a, 291 a and outer surfaces 271 b, 281 b, 291 bextending between near ends 276, 286, 296 and far ends 277, 287, 297,respectively. The far ends 277, 287, 297 of each cutting arm 270, 280,290 having cutting tips 274, 284, 294 for severing the tissue as barrel260 is rotated around first axis 259 and advanced along the first axis259 toward the targeted tissue. Trailing the cutting tips 274, 284, 294on the outer surface 271 b, 281 b, 291 b of the cutting arms 270, 280.290 is a cauterizing element 275, 285, 295. Each of the cutting arms270, 280, 290 has a supporting armature 272, 282, 292 (not shown) tohold the respective cutting arms in the open position. As the cuttingtips 274, 284, 294 and the rest of the arm is extended past therespective armature, the arms 270, 280, 290 will go from the openposition (see FIGS. 17A and 17B) to the closed position (see FIGS. 18Aand 18B). It should be understood that the presence of armatures 272,282, 292 extending from the distal end 262 of barrel 260 is just one ofmany variations contemplated as within the scope of the invention. Aspreviously mentioned, the exterior surface 264 of barrel 260 may alsoact as a supporting skeleton or framework for the respective arms, thusobviating the need for any separate armature. It should be furtherunderstood that the wide variety of mechanisms previously discussed forinducing the cutting arms to curve inwardly are equally applicable inthe present embodiment.

[0076] The above described embodiments of a biopsy device are intendedfor use with the previously described embodiments of a lymphostaticbreast stabilizing device, which fixes the breast in space usingnegative pressure, and allows anatomical access to all parts of thebreast using an image guided targeting device. The various embodimentsof the biopsy device allow accurate removal of tissue cores from thebreast; up to several centimeters in diameter; in a bloodless field.Other advantageous features include precise removal of cylindrical orbullet-shaped portions of the breast by a combination of cuttingstrategies using a unique tissue saw and coring device.

[0077] While the invention has been illustrated and described in detailin the drawings and foregoing description, the same is to be consideredas illustrative and not restrictive in character, it being understoodthat only the preferred embodiment has been shown and described and thatall changes and modifications that come within the spirit of theinvention are desired to be protected.

What is claimed is:
 1. A fixation apparatus for a breast comprising: acup-like body, said body having a side wall with an open top end and anopen bottom end and a fluid evacuation duct, said body defining achamber adapted to receive therein at least a portion of said breast; agasket attached to said bottom end, said gasket adapted to provide asubstantially fluid tight seal between said body and a first area ofskin around said breast; and, a suction ring attached to said top end,said ring adapted to provide a substantially fluid tight seal betweensaid body and a second area on said breast.
 2. The fixation apparatus ofclaim 1 , further comprising a hose attached to said fluid evacuationduct, said hose connecting said body to a pump capable of evacuatingfluid in said cup-like body when said body is mounted on said breastsuch that said gasket and said suction ring provide a substantiallyfluid tight seal between said body and said first and said second areasrespectively.
 3. The fixation apparatus of claim 1 , wherein saidcup-like body is frustospherical in shape.
 4. The fixation apparatus ofclaim 1 , wherein said cup-like body is funnel shaped.
 5. The fixationapparatus of claim 1 , wherein said fixation apparatus is manufacturedof materials which are transparent to MRI.
 6. The fixation apparatus ofclaim 1 , further including an adhesive to attach said gasket to saidfirst area and to attach said suction ring to said second area.
 7. Thefixation apparatus of claim 2 , further including a pressure gauge tomonitor the pressure within said cup-like body.
 8. The fixationapparatus of claim 1 , further including an interventional device and animaging device and an adjustable stage, wherein said suction ring ismounted on said adjustable stage, said adjustable stage securing saidinterventional device in an alignment, said imaging device for guidingthe alignment of said interventional device.
 9. The fixation apparatusof claim 1 , wherein said suction ring is mounted on a adjustable stage.10. The fixation apparatus of claim 9 , further including aninterventional device, said interventional device held in an alignmentby said adjustable stage, said alignment permitting precise excision ofa specimen of tissue from said breast.
 11. The fixation apparatus ofclaim 10 , further including an imaging, device, said imaging, devicefor guiding, the alignment of said interventional device.
 12. Thefixation apparatus of claim 10 , wherein said interventional device is abiopsy device.
 13. The fixation apparatus of claim 9 , wherein saidadjustable stage has a first portion with a first end and a second endand a second portion, said second portion of said adjustable stage beinggenerally ring shaped, said second end of said first portion beingconnected to said second portion.
 14. A fixation apparatus for aprotuberance of a body comprising: a cup-like body having a continuouswall and a port, said wall being open at one end, said wall defining avolume adapted to receive therein said protuberance of said body withoutsaid protuberance contacting said wall; and a gasket attached to saidend, said gasket adapted to provide a substantially fluid tight sealbetween said body and an area of skin around said protuberance.
 15. Thefixation apparatus of claim 14 , further comprising a tubular memberconnecting said port to a pump, said pump for removing fluid from saidvolume to create a reduced or negative pressure within said volume and apressure gauge connected to said fixation apparatus to monitor thepressure within said cup-like body.
 16. The fixation apparatus of claim14 , wherein said cup-like body is generally hemispherical in shape. 17.The fixation apparatus of claim 14 , wherein said cup-like body isfunnel shaped.
 18. The fixation apparatus of claim 14 , wherein saidapparatus is manufactured of materials which are transparent to MRI. 19.The fixation apparatus of claim 14 , wherein said gasket is attached tosaid area of skin using an adhesive.
 20. A minimally invasive tissue sawcomprising: a shaft extending along a first axis between a proximal endand a distal end, said shaft having a first cross section at the distalend; a cutting head extending between a connecting end and a cuttingend, at least a portion of the connecting end pivotally connected to thedistal end of said shaft so that at least a portion of said cutting headis able to swivel back and forth substantially along a second axis, thesecond axis in a direction transverse to the first axis; said cuttinghead having a cutting surface at said cutting end, said cutting surfaceextending across a width in the second axis, said cutting surface beingable to swivel back and forth to cut a slit in tissue, the slit having asecond cross section; said cutting head having at least one insertionsurface substantially adjacent said cutting surface, said insertionsurface extending between the connecting end and the cutting end, saidinsertion surface tapering from substantially the first cross section atthe connecting end to substantially the second cross section at thecutting end; and, wherein at least a portion of said insertion surfaceis a cauterizing element, said cauterizing element extendingsubstantially around a strip of said insertion surface, said elementcauterizing the tissue surrounding the slit.
 21. The tissue saw of claim20 , wherein said cutting surface is a serrated edge.
 22. The tissue sawof claim 20 , said insertion surface being a first surface and a secondsurface, said first and second surfaces generally facing oppositedirections, wherein at least a portion of said first surface is a firstcauterizing element and at least a portion of said second surface is asecond cauterizing element, each of said first and second surfaces aresubstantially adjacent the cutting surface.
 23. The tissue saw of claim22 , wherein said cutting surface is integrally formed with said firstsurface and said second surface.
 24. The tissue saw of claim 22 ,wherein said cutting surface is substantially adjacent said first andsecond cauterizing elements.
 25. The tissue saw of claim 22 , whereinthe portion of the cutting head pivotally connected to the distal end ofsaid shaft is the cutting surface, and the first surface and the secondsurface remain fixed with respect to the shaft when said cutting surfaceswivels back and forth.
 26. The tissue saw of claim 22 , wherein thefirst cauterizing element and the second cauterizing element are fixedto a portion of the first surface and second surface, respectively. 27.The tissue saw of claim 20 , wherein the entire cutting head swivelsback and forth.
 28. The tissue saw of claim 20 , wherein said firstcross-section is a circle with a first diameter, the width of saidcutting surface being equal to said first diameter, and wherein thecutting, surface is able to pivot from side to side at least a distanceof 0.2854 times the width of said cutting, surface along the secondaxis.
 29. The tissue saw of claim 20 , further including a retainingsleeve concentric with said shaft, said retaining sleeve enclosing saidshaft.
 30. The tissue saw of claim 20 , wherein said cutting surface isa generally circular bandsaw.
 31. The tissue saw of claim 30 , whereinsaid bandsaw has a diameter at least equal to π/2 times the diameter ofsaid shaft.
 32. The tissue saw of claim 31 , wherein said shaft is acylinder, and wherein said bandsaw may be detached from the distal endof said shaft, said bandsaw being collapsible so that it may beretracted through said shaft.
 33. The tissue saw of claim 22 , whereinthe first surface has a first taper from the first cross-section of theconnecting end to substantially the second cross-section at the cuttingend, and the second surface has a second taper from substantially thefirst cross-section at the connecting end to substantially thecross-section at the cutting end, and wherein the first and secondtapers are linear in profile.
 34. The tissue saw of claim 33 , whereinthe first taper is different from the second taper.
 35. The tissue sawof claim 20 , wherein the shaft is a cylinder, said tissue saw furthercomprising a plurality of cables for pivoting the cutting surface backand forth along the second axis.
 36. The tissue saw of claim 20 ,further including a plurality of orifices on said insertion surface forthe injection of at least one chemical directly to the tissuesurrounding a lesion to be excised.
 37. The tissue saw of claim 20 ,wherein said tissue saw is constructed of MR transparent material. 38.The tissue saw of claim 20 , further including a retaining sleeve, saidretaining sleeve concentric with said shaft, and further including acoring head, said coring head sized to fit within said retaining sleeve.39. A minimally invasive device for removing a specimen of tissuecomprising: a cylinder extending along and rotatable around a first axisdefined between a proximal end and a distal end, said cylinder having aninterior surface and an exterior surface; a plurality of cutting arms,each arm having an inner surface and an outer surface, said surfacesextending between a forward edge and a trailing edge, wherein at least aportion of the forward edge defines a cutting edge and wherein thecutting edge extends past the distal end of the cylinder to cut tissue;and, wherein said arms are pivotally connected to said cylindersubstantially at the distal end, said arms pivoting between an openposition and a closed position, the inner surface of each arm adjacentand substantially overlapping the exterior surface of said cylinder inthe open position, and wherein at least a portion the inner surface ofeach arm extends beyond the distal end of said cylinder and is adjacenttissue in the closed position.
 40. The device of claim 39 , wherein atleast a portion of the outer surface of each arm is a cauterizingelement, the cauterizing element cauterizing the tissue surrounding thespecimen of tissue to be removed.
 41. The device of claim 39 , whereineach arm has a pivoting end and a far end, the forward edge and thetrailing edge extending between thed pivoting end and the far end, eachof said arms pivoting substantially around the pivoting end.
 42. Thedevice of claim 41 , wherein the far end is adjacent and substantiallyoverlapping the exterior surface of said cylinder in the open position,and wherein the far end has been pivoted 90 degrees in a direction awayfrom the distal end of the cylinder in said closed position.
 43. Thedevice of claim 41 , wherein each of said arms is made of a materialhaving a memory, said memory causing said arms to curve inwardly towardone another as the far end is pivoted from the open position to theclosed position.
 44. The device of claim 43 , wherein said arm is madeof a shape memory material.
 45. The device of claim 41 , furtherincluding a supporting armature attached to said cylinder, said armscurving inward toward one another as they move between said openposition wherein said arms are substantially adjacent the armature tosaid closed position wherein at least a portion of each arm no longeroverlaps the armature.
 46. The device of claim 41 , further including aspring located between the pivoting end of the inner surface of each ofsaid arms and the exterior surface of said cylinder, the spring causingthe far end of each arm to curve inwardly as the far end is pivoted fromthe open position to the closed position.
 47. The device of claim 45 ,wherein said cylinder acts as the supporting armature.
 48. A minimallyinvasive tissue biopsy device comprising: a cannula having a proximalend and a distal end; a first longitudinal axis defined between saidends; means for cutting a slit in tissue, the slit in a second axissubstantially transverse to said first longitudinal axis; and trailingmeans for cauterizing substantially all tissue surrounding the slit. 49.The biopsy device of claim 48 , further comprising means for coring asection of tissue adjacent the distal end of said cannula.
 50. Thebiopsy device of claim 49 , wherein said means for coring is introducedto the system around the exterior of said cannula.
 51. The biopsy deviceof 49, wherein said means for coring goes through said cannula after theremoval of said means for cutting.
 52. The biopsy device of claim 49 ,wherein said means for coring goes through said cannula around saidmeans for cutting.
 53. A method comprising: providing a retaining sleevehaving a proximal and a distal end, said retaining sleeve having a firstcross-section at the distal end; providing a tissue saw with anoscillating cutting head and a trailing coagulating element, said headhaving a cutting edge and a tapering insertion surface; advancing saidretaining sleeve and said tissue saw along a first axis toward a lesionwhile said cutting edge oscillates back and forth and cuts an entrywound in tissue, the entry wound being a substantially linear slit, theslit having a second cross-section; distorting the entry wound from thesecond cross-section of the slit to the first cross-section of theretaining sleeve; and, cauterizing tissue surrounding said slit withsaid trailing coagulating element, said cauterization occurring as saidtissue saw and said retaining sleeve are advanced toward said lesion.54. The method of claim 53 , further comprising removing said tissue sawthrough said retaining sleeve.
 55. The method of claim 53 , furthercomprising halting the tissue saw and retaining sleeve along the firstaxis prior to reaching the lesion.
 56. The method of claim 53 , furthercomprising providing and advancing an interventional device through saidretaining sleeve to said lesion.
 57. The method of claim 53 , furthercomprising providing and advancing a coring device up to a distal end ofsaid retaining sleeve and coring out a specimen of tissue surroundingthe lesion.
 58. The method of claim 57 , further comprising cauterizingthe tissue surrounding the specimen with said coring device.
 59. Themethod of claim 58 , further comprising withdrawing the specimen oftissue through said retaining sleeve.
 60. The method of claim 53 ,further comprising withdrawing the retaining sleeve and allowing theentry wound to collapse from the first cross section to the second crosssection.
 61. The method of claim 53 , further comprising injectinganti-cancer agents into the tissue.